Tokyo, April 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061352) titled 'Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates' on April 22.

Study Type: Observational

Primary Sponsor: Institute - Hamamatsu University School of Medicine Hospital

Condition: Condition - Malignancy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the pharmacokinetics of unconjugated MMAE and the clinical outcomes in cancer patients initiating treatment with MMAE-based antibody-drug conjugates (ADCs), and to investigate their associations with patient-related factors, including CYP3A activity biomarkers, geriatric assessments, and body composition parameters. The aim of this study is to identify predictors of efficacy, safety, and treatment intensity of MMAE-based ADCs. Basic objectives2 - Pharmacokinetics

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be included:

1. Patients diagnosed with a malignant tumor 2. Patients initiating treatment with enfortumab vedotin, tisotumab vedotin, or polatuzumab vedotin 3. Patients aged 18 years or older 4. Patients who have provided written informed consent for participation in this study Key exclusion criteria - Patients who meet any of the following criteria will be excluded:

1. Patients who are unable to provide written informed consent 2. Patients deemed inappropriate for inclusion in this study by the treating physician Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070043

Disclaimer: Curated by HT Syndication.